U.S. patent number 5,474,544 [Application Number 08/345,808] was granted by the patent office on 1995-12-12 for luer-receiving medical valve.
Invention is credited to Lawrence A. Lynn.
United States Patent |
5,474,544 |
Lynn |
December 12, 1995 |
Luer-receiving medical valve
Abstract
A luer receiving medical valve for the sterile transfer of fluid
from a luer-tapered male end having a surrounding female luer lock
threaded end. The luer receiver includes a housing having an inlet
and an outlet and a lumen extending from the inlet to the outlet.
An elastomeric sealing member occludes the inlet and has a slit
extending through it. In a preferred embodiment, a support is
provided adjacent the housing inlet and adjacent the sealing
member. The support includes opposing posts separated by slots, the
slots permitting expansion of the sealing member when the male luer
is inserted into the slit.
Inventors: |
Lynn; Lawrence A. (Worthington,
OH) |
Family
ID: |
26939480 |
Appl.
No.: |
08/345,808 |
Filed: |
November 22, 1994 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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248646 |
May 25, 1994 |
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Current U.S.
Class: |
604/537; 128/912;
251/349 |
Current CPC
Class: |
A61M
39/02 (20130101); A61J 1/2096 (20130101); Y10S
128/912 (20130101); A61J 1/2044 (20150501); A61J
1/201 (20150501); A61J 1/2058 (20150501) |
Current International
Class: |
A61M
39/02 (20060101); A61J 1/00 (20060101); A61M
5/24 (20060101); A61M 025/00 () |
Field of
Search: |
;128/912
;251/4,334,340,347,349
;604/33,169,200,204,231,236,237,246,247,249,250,256,283,905 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
Brochure by McGaw, The Clave.TM. IV Administration System. .
Sample of Buron One-Way Valve System..
|
Primary Examiner: Rosenbaum; C. Fred
Assistant Examiner: Tsosie; Bryan L.
Attorney, Agent or Firm: Cushman, Darby & Cushman
Parent Case Text
FIELD OF THE INVENTION
This is a continuation-in-part of application Ser. No. #08/248,646,
filed May 25, 1994 (the disclosure of which is hereby incorporated
by reference as if completely disclosed herein). This invention
relates to the safe and sterile transfer of medical fluid, in
particular intravenous fluid and to the sampling of blood as from
indwelling arterial and venous catheters and the like. The
invention particularly relates to the administration of intravenous
fluid or pharmaceuticals to a patient. The background and: problems
associated with fluid and drug administration and with blood
sampling are extensively discussed in my U.S. Pat. No. 4,838,855,
Blood Aspiration Assembly and Method, issued Jun. 13, 1990; U.S.
Pat. No. 5,178,607, Blood Aspiration Assembly Septum and Blunt
Needle Aspirator, issued Jan. 12, 1993; U.S. Pat. No. 5,137,524,
Universal Intravenous Connector with Dual Catches, issued Aug. 11,
1992; U.S. Pat. No. 4,946,445, Intravenous Line Coupling Device,
issued Aug. 7, 1990; U.S. Pat. No. 5,215,537, Septum for a Blunt
Cannula, issued Jun. 1, 1993; and U.S. Pat. No. 5,167,643, Needle
Protection Station, issued Dec. 1, 1992 (the disclosure of each of
these patents is hereby incorporated by reference as if completely
disclosed herein). These patents provide additional background for
the present invention.
Claims
I claim:
1. A medical luer receiver for the sterile transfer of fluid from a
luer-tapered male end having a surrounding female luer lock
threaded end, comprising:
a. a housing having an inlet and an outlet and a lumen extending
from said inlet to said outlet;
b. an elastomeric sealing member defining a longitudinal axis and
having a central portion and occluding said inlet, said sealing
member having an outerface;
c. a slit extending through said sealing member, said slit defining
a long transverse axis transverse to said longitudinal axis, and
further having a length along said long transverse axis sufficient
to receive said male end into said slit;
d. a support portion defining a longitudinal axis, said support
portion being positioned adjacent said inlet and adjacent said
sealing member;
e. said support portion including opposing posts and slots defined
therebetween, said slots functioning to allow expansion of said
sealing member when said male end is inserted into said slit.
2. The receiver of claim 1 wherein said sealing member defines an
elongated cross-section transverse said sealing member longitudinal
axis, said sealing member defining opposing lateral walls adjacent
said long transverse axis of said slit.
3. The receiver of claim 2 wherein said slots are positioned
adjacent said sealing member such that said lateral walls are
deflected into said slots when said male end is received into said
slit of said sealing member.
4. A medical connection system for the sterile transfer of fluid,
comprising:
a. a luer-lock connector including an open female cylindrical end,
said end defining an interior threaded wall, said connector further
including a cannula centrally positioned within said cylindrical
female end, said wall and said cannula defining a partially
enclosed narrow tubular space intermediate said cannula and said
wall,
b. a connection terminal including a housing having an inlet and an
outlet, said housing adjacent said inlet being sized to be received
within said tubular space,
c. an elastomeric sealing member mounted within said inlet, said
member defining a longitudinal axis, said member further defining a
proximal end portion adjacent said inlet, said proximal end portion
including an outer face,
d. a perforation extending through said sealing member, at least a
portion of said perforation being capable of receiving at least a
portion of said cannula by penetration of said cannula into said
perforation, said cannula upon said penetration displacing at least
a portion of said sealing member transverse to said axis to define
a displaced member,
e. said housing having at least one cutout adjacent said inlet,
said cutout functioning to receive at least a portion of said
displaced member into said tubular space when said cannula is
received into said perforation so that said housing adjacent said
inlet and at least said proximal end portion of said sealing member
can be received into said female cylindrical end when said cannula
is received into said perforation.
5. The system of claim 4 wherein said housing adjacent said inlet
includes at least one flange for engaging said threaded wall so
that said female cylindrical end can be threaded onto said housing
to securely connect said female end to said housing.
6. The system of claim 4 wherein said housing includes at least one
cantilevered bar adjacent said inlet sized for being received
within said tubular space of said female end.
7. The system of claim 6 wherein at least two directly opposed
cantilevered bars are provided adjacent said inlet.
8. The system of claim 7 wherein said bars define slots
intermediate said bars for receiving said displaced member of said
sealing member.
9. The system of claim 8 wherein said bars are directly opposed,
said sealing member being mounted intermediate said directly
opposed bars.
10. The system of claim 9 wherein said perforation is a slit.
11. The system of claim 10 wherein said slit is aligned with said
bars such that said slit extends from adjacent one said bar to a
position adjacent the bar opposing said one bar.
12. A medical connection terminal for secure connection of a luer
lock connector having a female threaded end, said connector having
a cannula centrally disposed within said female end, the terminal
comprising:
a. a rigid housing defining an axis and having a proximal portion
and a distal portion, said housing having an inlet adjacent said
proximal portion and an outlet adjacent said distal portion, said
proximal portion having at least one cutout adjacent said
inlet,
b. an elastomeric sealing member mounted within said inlet, said
member having an outer face and a sealed perforation extending
through said member from adjacent said outer face toward said
outlet, said perforation being sized to receive said cannula, said
member expanding adjacent said outer face to define an expanded
sealing member when said cannula is received within said
perforation, at least a portion of said expanded member expanding
into said cutout, said expanded member and said proximal portion of
said housing being sized to be threadably received within said
female end so that when said cannula is inserted into said
perforation, said female end can be threadably locked over said
proximal portion of said housing.
13. A medical connection terminal of claim 12 wherein said proximal
portion of said housing includes at least two cutouts.
14. The medical connection terminal of claim 13 wherein said
cutouts are oppositely disposed, said housing further including at
least two oppositely disposed cantilevered bars intermediate said
cutouts.
15. The medical connection terminal of claim 14 wherein said
perforation is a slit.
16. The medical connection terminal of claim 15 wherein said
sealing member defines a longitudinal axis and wherein said slit
defines a longitudinal axis transverse to said sealing member
longitudinal axis, said slit dividing said sealing member into
oppositely disposed lateral portions, said longitudinal axis of
said slit being aligned with said bars so that when said cannula is
received into said slit, said oppositely disposed lateral portions
are displaced by said cannula into said cutouts.
17. The medical connection terminal of claim 16 wherein said
sealing member includes a proximal portion and a distal portion,
said proximal portion of said sealing member having an elongated
cross-section defining a major axis, said longitudinal axis of said
slit extending along said major axis.
18. The medical connection terminal of claim 17 wherein said
proximal portion of said sealing member is more compliant than said
distal portion.
19. The medical connection terminal of claim 12 further including
at least one strap member connected to said sealing member, said
strap member extending through said cutout, said strap member
functioning to secure said sealing member to said housing in said
mounted position within said inlet.
20. A medical luer lock connection system comprising:
a. a male connection terminal defining a rigid housing having an
inlet and an elastomeric sealing member mounted within said
inlet,
b. a cylindrical female connection terminal including cylindrical
interior walls, said interior walls including a locking member for
locking onto said rigid housing, said female terminal having a
centrally disposed blunt cannula projecting therein, said female
terminal defining a narrow tubular open space intermediate said
central cannula and said interior walls, said female terminal being
sized to be received over said housing adjacent said inlet,
c. a sealed perforation through said elastomeric sealing member for
receiving said cannula,
d. said housing including a proximal portion adjacent said inlet,
said proximal portion including oppositely disposed slots, said
proximal portion of said housing further being sized to be received
within said tubular open space of said female connection
terminal,
e. said blunt cannula displacing at least a portion of said
elastomeric sealing member into said slots when said cannula is
received into said perforation to define a displaced member, said
slots functioning to receive at least a portion of said displaced
member,
f. said proximal portion of said housing, and at least a portion of
said displaced member within said slots being received into said
narrow space when said cannula is received into said perforation
and said female connection terminal is locked onto said housing of
said male connection terminal.
21. The connection system of claim 20 wherein said narrow tubular
open space is approximately 3 mm or less in width.
22. The connection system of claim 21 wherein said cannula has an
approximate diameter of 3-4 mm.
23. The connection system of claim 22 wherein said female
connection terminal has an internal diameter intermediate said
interior walls of approximately 7-8 mm.
24. The connection system of claim 23 wherein said perforation is a
slit having a length approximately equal to the diameter of said
cannula.
25. A medical connection system comprising:
a. a first terminal including a luer lock connector, said connector
having a cylindrical female end and a blunt cannula centrally
disposed within said end,
b. a second terminal including a housing having an inlet and an
outlet and defining a housing portion adjacent said inlet, said
portion including at least one cutout, said housing portion being
sized to be received into said female end of said first
terminal,
c. an elastomeric sealing member disposed within said inlet of said
second terminal, said member having an outer face and being mounted
with said second terminal such that said outer face is adjacent
said inlet, said sealing member having a perforation extending from
said outer face through said sealing member for receiving said
cannula, said sealing member, and said cutout being configured such
that said sealing member can expand into said cutout when said
cannula is inserted into said perforation, said housing portion
with said sealing member being sized so as to be received into said
female end when said cannula is received into said perforation and
said sealing member has expanded into said cutout.
26. A connection system for connecting a first tubing system with a
second tubing system, said system including:
a. a female terminal comprising a cylindrical female luer lock
connector defining interior threaded walls and having a cannula
centrally disposed within said connector,
b. a male terminal comprising a rigid housing defining an axis and
having a proximal portion including an inlet and a distal portion
including an outlet, said proximal portion having opposing
cantilevered bars and further having opposing slots intermediate
said bars, said bars including at least one flange, said bars being
sized to be received within said female luer lock connector such
that said flange can engage said interior threaded walls,
c. an elastomeric sealing member mounted within said inlet and
having a closed central perforation through said member, said
perforation being sized to receive said cannula, at least a portion
of said sealing member deflecting upon receipt of said cannula into
said perforation to define at least one deflected sealing member
portion, said sealing member, said bars, and said cutouts being
sized and configured so that said bars and said sealing member can
be received into said female luer lock connector when said cannula
is advanced into said perforation so that said female luer lock
connector may be threadably locked about said proximal portion when
said centrally positioned cannula is received within said
perforation.
Description
BACKGROUND AND SUMMARY OF THE INVENTION
The risk of needlestick injury and the expense associated with
accessory cannulae, whether blunt or sharp, are well known.
Conventional intravenous tubing systems utilize tapering luer male
cannula connectors, often within an associated surrounding
threadable member defining a luer-lock connector commonly used for
achieving tight, sustained connections. A bare luer taper cannula
without the associated threadable member is commonly called a luer
slip connector and is widely utilized for brief prn injections.
Both of these luer systems are in wide use throughout conventional
hospital systems and it would be preferable to develop a connecting
valve system which receives and is activated by conventional luer
slip tapers or luer lock tapers so that incorporation into existing
hospital systems is rapid and associated with minimal cost. It
would be advantageous for such systems to avoid deadspace so that
the surface could be easily wiped with antiseptic to avoid the need
for capping after each use. Furthermore, the elimination of
deadspace allows for the aspiration of blood through such systems
without the collection of blood within the deadspace. Another
important feature of such systems is the minimization of
"kickback"--that is, it is important that the luer slip tip or luer
lock systems, when not tightly locked, do not kickback out of the
valve, thereby producing the potential for a spurt of blood or
fluid into the environment and potential contamination of the
operator.
The prior art includes several luer-receiving valves which do not
have substantial deadspace. U.S. Pat. No. 5,201,725 shows a valve
which utilizes an elastomeric member which opens by force induced
by a threadable member over the elastomeric septum piston. Such a
system will not work with a conventional luer lock system since the
role taper extends centrally adjacent the luer lock threading
member and therefore, it would not be possible to compress the
septum piston within the luer-lock threads in such a system without
inserting the male member itself into the septran piston. The
background discussed in the aforementioned patent provides
additional background for the present invention.
A device, designated the CLAVE.TM., for an injection port marketed
by McGaw, is included in the Prior Art. This device utilizes a
cannula surrounded by a septum piston. The septum piston is
compressed by the luer taper, thereby allowing the needle and its
associated bore to enter the bore of the luer taper, thereby
opening fluid communication. However, such systems would be
expected to be associated with substantial kickback when used with
a luer slip system since the septum piston must be relatively
resilient to prevent leakage associated with higher fluid pressures
within the cannula. Further, tile requirement of a spike or cannula
within the bore of the valve results in considerable increase in
expense associated with complex insert molding of the device. It
is, therefore, preferable to develop a more simplified valve system
which can receive a luer taper cannula and which eliminates the
need for complex insert molding to minimize the potential for
kickback and the potential for trapped fluid or blood while still
providing a deadspace-free surface which can be easily wiped with
antiseptic. Such a device also will not receive a blunt cannulae
and, therefore, may be difficult to implement with conventional
drug delivery systems.
In general, the present invention comprises a housing including a
main conduit having a main bore and further having a branch
extending away from the main conduit and including a secondary bore
extending through the branch in fluid communication with the main
conduit. The secondary bore may be aligned directly with the main
conduit or may branch from the main conduit. The main conduit may,
for example, comprise a catheter or may be a primary intravenous
tubing system or arterial line. The secondary bore defines a
longitudinal axis. An elastomeric septum piston is disposed within
the secondary bore and at least a portion of the elastomeric septum
piston is moveable by either compression or by longitudinal
advancement along the secondary bore toward the main bore. In one
preferred embodiment, the septum piston is cylindrical and includes
a centrally positional slit extending along the longitudinal axis
of the cylindrical septum piston. The cylinder includes a proximal
end and a distal end. The proximal end preferably extends to a
position adjacent the proximal end of the secondary bore so that
the surface of the proximal end of the septum piston is easily
accessible adjacent the proximal end of the branch and therefore
can be easily wiped with antiseptic. This is an important feature
since it eliminates the need for capping after blood aspiration or
drug injection. The bore of the secondary branch preferably
includes two opposing projecting members along a distal portion of
the bore which effectively narrow the diameter of the bore along at
least a portion of one longitudinal axis. In the preferred
embodiment, the central slit through the septum piston defines a
longitudinal axis transverse to the longitudinal axis of the septum
piston. With this embodiment, the longitudinal plane of the
narrowed distal portion of the secondary bore is aligned with the
longitudinal axis of the slit through the elastomeric septum
piston. Furthermore, the elastomeric septum piston is sized to be
transversely compressed by the projecting distal portions of the
secondary bore. Since the slit is aligned with the projecting
portions, transverse compression of the septum piston occurs along
an axis which corresponds with the longitudinal axis of the slit so
that when the elastomeric member is pushed from a proximal position
into a distal position, the elastomeric member is transversely
compressed by the projecting portions along the distal secondary
bore, the compression causing the formerly tightly-closed slit to
shorten and thereby open, allowing fluid to pass through a nascent
flow channel formed by the shortened slit through the elastomeric
septum piston. When the septum piston retracts away from the distal
portion back into the proximal portion, the slit returns to its
tightly closed position, thereby occluding further fluid
communication through the septum piston.
In the preferred embodiment, the projecting portions progressively
lengthen to define a progressively decreasing distance between the
projecting members so that the projecting members are closer to one
another adjacent the main bore than adjacent the proximal
cylindrical portion of the secondary bore. This effectuates a
progressive enlargement of the opening through slit of the
elastomeric septum piston when the elastomeric septum piston is
fully advanced into the proximal portion of the secondary bore.
Furthermore, after removal of the luer, as the elastomeric septum
piston retracts away from the distal compressing portion toward the
proximal portion, the slit progressively closes from its proximal
extent toward its distal extent, thereby expressing fluid toward
the main bore rather than toward the proximal opening of the
secondary bore. This reduces the chance of blood or fluid refluxing
out of the septum piston into the environment or into the secondary
bore when luer taper cannula is withdrawn from the secondary
bore.
The septum piston can include a proximal extension which can be
cylindrical and can be integral with the septum piston and can be
formed of like elastomeric material such as silicone or latex
rubber. The septum piston and the extension can be formed together
as a single integral flexible conduit having an interior sterile
enclosed flow path. In one embodiment, the proximal end of the
conduit is closed to comprise the septum piston having a sealed
perforation, as described above;the distal end of the conduit is
opened and engages a seat which can provide a seal. The conduit
therefore provides an enclosed flow path from the luer tip through
the conduit when the closed end of the conduit is distorted such
that the perforation is open. The distal open end of the conduit
can be intussuscepted over a tube which can be rigid so as to
provide a fixed sealed seat. Alternatively, the seat can be
provided by a slot formed within an outer housing. An advantage of
the tubular seat is that it provides easy mounting of the tubular
flexible conduit during manufacture and further can provide an
effective seal against contamination of the interior flow path
within the flexible conduit during operation. It is considered
potentially advantageous to provide an enclosed sterile central
flow path which does not contact the housing to thereby minimize
the potential for contact contamination of the flow path.
It can be seen that the flexible conduit in conjunction with the
seat can provide both a sealed interior flow path and can further
provide an additional elastic spring force when mounted with the
rigid seat such that longitudinal force applied by insertion of the
luer to the closed end of the conduit results in either
longitudinal compression or folding of the tubular conduit which
will then rebound to its original position when the longitudinal
force applied by the luer tip is removed. Since the flow path need
not engage the housing, the housing can be provided as only an
incomplete cylinder or can be provided as linear support struts,
thereby increasing visibility of the flexible conduit and fluid
path and allowing more open access to the tabular seat for more
easy molding and mounting of the flexible tubular conduit with the
seat during manufacture.
In one embodiment, the proximal face of the septum piston of the
tubular conduit is soft such that the face will mold with the
distal tip of the luer when the luer tip is advanced against the
face, thereby providing enhanced sealing of the luer with the face.
The face can also include a circumferential membranous apron
extending lateral to the face and over the distal end of the
housing of the branch. The apron can then be deflected inwardly by
the housing as the septum piston is advanced, thereby providing an
additional circumferential seal for the luer tip. The rigid tube
can be provided as a wedge or tapered cone member to assist in
distorting the septum piston perforation into the open
position.
A flow deflector or ramp can be provided when the housing of the
branch is mounted to a tubing system to form a secondary branch, as
in a T or Y configuration. The flow deflector can ramp flow into
deadspace within the flexible conduit or rigid tubular seat so as
to minimize the trapping of air bubbles or blood within the seat or
flexible conduit when the device is used in blood sampling
configurations, such as with arterial lines.
The branch of the main conduit can be aligned directly with or
perpendicular to the main conduit or can be at an oblique or acute
angle with the main conduit. The main conduit is generally
discussed below as integral with the valve, but the main conduit
may be a separate piece and sold separately, and may be joined with
the branch or the aligned secondary bore by a threadable member as,
for example, joining a conventional heparin well or prn adapter to
a catheter, stopcock, or IV tubing system.
The branch preferably includes at least one external thread or
thread receiver for receiving an internal female threading member
to allow a secure threaded connection with a conventional luer-lock
type connector of the type commonly used with conventional syringes
or intravenous tubing systems.
The use of this luer-activated valve in association with IV
piggyback administration generally would require the recapping of
the luer taper after use so that the luer taper remains sterile
between IV piggyback mediation administrations. My U.S. Pat. No.
5,167,643 (the disclosure of which is hereby incorporated by
reference as if completely disclosed herein) describes a Docking
Station for receiving a blunt cannula such as a tapered luer end to
maintain the sterility of the tapered end. The present invention
includes the secondary tubing system having a docking station
intended for use with a conventional luer taper cannula of the slip
tip or luer lock type. This station utilizes a simple membranous
cover since the primary function of the cover is to cover and seal
the luer within the station, as discussed in the previous patent.
The new protection station may include an annular shield for
protecting the fingertips against inadvertent contact of the luer
taper since the luer taper has been removed from fluid connection
with the patient's blood vessel and, therefore, could be
contaminated by potentially infectious material which, by even
surface contamination of a nurses fingers, could subsequently enter
a fissure in the fingers or otherwise be transferred to a mucous
membrane where infection could ensue. The station preferably
includes a connecting portion for connecting to a proximal portion
of the intravenous piggyback system or supporting pole, as
described in my aforementioned patent. The combination of a primary
fluid system which incorporates a luer-activated valve and a
secondary system which incorporates a luer cannula protection
station which protects the tapered blunt cannula of the luer
provides reliable intermittent connection to the patient with
assurance that the luer taper remains sterile between use and
eliminates the need for the utilization of multiple caps, thereby
reducing overall cost.
It is the purpose of the present invention to provide an
inexpensive medical valve which can be activated by a conventional
luer taper cannula and thereby be widely implemented within
existing hospital systems.
It is further the purpose of the invention to provide a valve with
a central sealed flow path through a flexible conduit, thereby
minimizing the potential for contamination of the flow path and
allowing for insertion of conventional blunt cannulae.
It is further the purpose of this invention to provide a medical
valve which can be easily wiped with antiseptic to eliminate the
need for recapping after use. It is further the purpose of this
invention to provide a medical valve having substantially no
deadspace adjacent its proximal portion to eliminate the pooling of
blood or liquid within the valve so that the valve may be
repetitively used for the aspiration of blood and reinjection of
liquids.
It is further the purpose of this invention to provide a
luer-activated opening of a central fluid path which is
automatically aligned with the bore of the luer and which will
directly communicate with the bore of a luer taper cannula upon the
transmission of longitudinal force of the luer taper cannula
against the septum piston, thereby providing a mechanism for the
opening of a centrally-positioned fluid path at the same time tight
sealing occurs adjacent the distal end of the luer taper cannula
against the septum piston. It is further the purpose of this
invention to provide a valve which progressively closes from its
proximal extent to its distal extent, thereby expressing residual
fluid from the valve away from the environment. It is further the
purpose of this invention to provide a two-piece valve which can be
simply manufactured by the insertion of an elastomeric septum
piston into a rigid tubular structure, thereby avoiding the need
for expensive and complex insert molding.
These and other features will become evident from the summary and
detailed description described below. Furthermore, these and other
objects and advantages of the invention will be further set forth
in the description which follows and, in pan, will be learned from
the description or may be learned by practice of the invention. The
objects and advantages of the invention may be realized by means of
the instrumentalities and combinations particularly pointed out in
the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a partial perspective view of a longitudinal section of
the luer-receiving valve with the piston septum being in its
resting detented position.
FIG. 2 is a partial perspective view of a longitudinal section of
the luer-receiving valve with the blunt luer taper cannula of the
conventional slip-tip type fully inserted into the cylinder.
FIG. 3 is a perspective view of a section through lines 3--3 of
FIG. 1.
FIG. 4 is a top view of the septum piston in its resting state.
FIG. 5 is a top view of the septum piston in its fully advanced
compressed state, showing the open slit.
FIG. 6 is a side view of the septum piston of FIG. 1.
FIG. 6A is a side view of a septum piston having an additional
distal portion for occluding the main channel and including a
proximal elastic umbrella.
FIG. 6B is a side view of a septum piston showing the distal
portion for occluding the main channel.
FIG. 6C is another embodiment showing the proximal soft and
compressible deadspace filler in association with the septum
piston.
FIG. 7 is an exploded perspective view of a longitudinal section of
a valve having a flexible seated conduit.
FIG. 7A is a perspective view of a longitudinal section, according
to FIG. 7, with the proximal end of the conduit displaced into the
distal position and the perforation biased into an open
position.
FIG. 7B is a perspective view of a longitudinal section showing a
modified flexible conduit having a tapered outer face.
FIG. 7C is a perspective view of a longitudinal section, according
to FIG. 7B, showing the proximal end of the flexible conduit
displaced into the distal position with the slit biased into an
open position.
FIG. 8 is a perspective view of a longitudinal section showing an
elongated septum piston.
FIG. 9 is a perspective view of a longitudinal section of an
embodiment having an elongated septum.
FIG. 9A is a perspective view of a longitudinal section, according
to FIG. 9, with the occluding piston displaced such that the slit
is distorted into the open position.
FIG. 9B is a longitudinal section view of an embodiment having a
flow deflector and a wedge-shaped tubular seat.
FIG. 9C is a transverse section through lines 9C--9C of FIG.
9B.
FIG. 10 is a perspective view of a luer tapered cannula protection
station.
FIG. 11 is a longitudinal section view of a luer tapered cannula
protection station showing an adjacent conventional luer lock
connector.
FIG. 12 is a perspective view of a longitudinal section of an
embodiment having opposing supporting bars and intervening slots
adjacent the septum.
FIG. 12A is a perspective view of a longitudinal section through
the slit along lines 12A--12A of FIG. 12.
FIG. 12B is a partial top view of the embodiment of FIG. 12 and
FIG. 12A, illustrating the relationship of the conventional male
luer end to the septum face.
FIG. 12C is a perspective view of the flexible tubular container
without the proximal apron.
FIG. 12D is a partial top view through sections 8D--8D of FIG. 12C,
showing the relationship of the longitudinal slit to the walls of
the septum.
FIG. 12E is a partial section view, according to 12D, showing the
luer taper received into the slit.
DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS
In one preferred embodiment, the luer tapered cannula receiving
valve 5 (FIGS. 1-6) includes a main conduit housing 10 having a
main bore 14 and a secondary branch or cylinder 18 having a
secondary bore 22. The cylinder 18 includes a distal end 26
adjacent the main bore 10 and a proximal end 30. The cylinder 18
further includes a cylindrical proximal bore portion 34 sized to
sealingly receive a conventional tapered luer male cannula 35 (as
shown in FIG. 2) and distal bore portion 38. The proximal bore
portion 34 is defined by inner cylindrical walls 42 and outer walls
43 and includes outer thread receiving post 44 adjacent the
proximal end 30 (although complete outer threads may be provided).
A distal bore portion 38 is defined by distal wall 46 having
opposing projecting members 50 which effectively narrow the
transverse width of the distal bore portion 38 along a longitudinal
plane through the opposing projecting members 50 (as best shown in
FIG. 3). A cylindrical elastomeric septum piston 60 having a distal
end 61 and a proximal end 62 is provided and includes a centrally
positioned slit 72 extending from the proximal end 62 to the distal
end 61 which can, if desired, receive a steel blunt cannula or
sharp needle (not shown). The elastomeric septum piston 60 can be
comprised, for example, of silicone rubber or of latex rubber and
is both resilient and compressible. The septum piston 60 is
preferably sized to be tightly received within the cylindrical
proximal bore portion 34 so as to effectively sealingly wipe the
cylindrical side walls 42 of the proximal bore portion 34 upon
movement of the proximal end 62 of the septum piston 60 back toward
the proximal end 30 of the cylinder 18, as will be discussed.
In the preferred embodiment, a silicone lubricant is provided to
enhance the sliding piston-like action of the sealingly received
septum piston 60 against the side walls 42 and 46 of the cylinder
18. As noted previously, the slit 72 extends completely through the
cylindrical septum piston 60. The long transverse axis of the slit
72 (in the transverse plane of the septum piston) is aligned within
the same plane as the longitudinal axis through the opposing
projecting members 50 of the distal bore portion 38 (FIG. 1 ).
Furthermore, the transverse diameter of the distal bore portion
along an axis perpendicular to the longitudinal plane of the
projecting members 50 can be slightly greater than the transverse
diameter of the septum piston 60 to thereby, during operation,
receive a bulging portion of the septum piston 60, as will be
discussed.
A septum wiper 78 is provided and a bore detent 79 is provided to
retain the elastomeric septum piston 60 within the secondary bore
by receiving the septum wiper. The wiper 78 is flexible to provide
a tight seal. A second wiper (not shown) can be provided adjacent
the proximal end 62 to provide additional sealing. The wiper 78
includes a partial recess 79 for receiving the projecting members
50 to allow tight sealing when passing over the members 50. After
insertion, during manufacture, the septum wiper 78 engages the
detent 80. As shown, the septum wiper 78 is configured so as to
allow distal displacement of the septum piston 60 out of its
detented position (of FIG. 1), but to prevent proximal bore
displacement of the septum piston 60 out of its detented
position.
In operation, when a connection, injection, or aspiration is
required, a conventional luer taper cannula 35 having a central
opening 94 is inserted into the proximal bore portion 34 of the
cylinder 18. Advancement of the luer taper cannula 35 causes
longitudinal displacement of the septum piston 60 from within the
proximal bore portion 34 into the distal bore portion 38 between
the projecting portions 50. This causes compression of the septum
60 in an axis which is aligned with the long transverse axis of the
longitudinal slit 72 so that the slit 72 is transversely shortened,
and thereby opened to define an open fluid flow channel 100. The
formerly cylindrical septum piston 60 is narrowed in one transverse
axis and bulges and widens in the perpendicular transverse axis,
thereby producing an ellipse with a shortened and now opened
central slit 72 (FIG. 2 and FIG. 5), although the actual
configuration within the cylinder may be limited in situ by the
cylinder wall 46. As noted previously, the projecting members 50
progressively enlarge to progressively narrow the width of the
distal portion 38 between the projecting members 50. If the
elastomer is soft, this will cause the slit 72 to progressively
shorten from its proximal extent toward its distal extent and,
therefore, the flow channel 100 will be narrower in the proximal
extent and wider toward the distal extent. If the elastomer is
comprised of a harder elastomer such as high durometer silicone,
for example, exceeding 60 durometer-A medical grade, then the slit
72 will be wedged widely open along its entire length.
After the injection or aspiration is complete, the luer taper
cannula 35 is withdrawn from the proximal portion 34 of the
cylinder 18. Upon removal of the luer taper cannula 35, the septum
piston 60 rebounds gently from its formerly advanced position back
into its proximal sealing position with the proximal end of the
septum piston returning to a position adjacent the proximal end 30
of the cylinder 18. The lubrication of the septum piston 60 and the
progressive narrowing of the opposing members 50 causes the
resilient septum piston 60 to rebound back from its advanced
position. By using a slowly progressive taper, the force of the
rebound can be minimized to prevent kickback of the luer 35 from
the proximal portion 34 of the cylinder 18. In addition, an
umbrella, as will be discussed, could be attached so as to provide
less redundancy and, therefore, to provide elastic rebound. As
discussed previously, during the return of the septum piston 60
back toward its resting position, the flow channel 100 can
progressively close from its proximal extent to its distal extent
to effectively express any liquid contained within the flow channel
100 back toward the main bore 10, rather than out toward the
cylinder 18.
It can be seen that, by utilizing the achievement of lateral
compression by the application of longitudinal displacing force
against the septum piston, the rebound force of the septum piston
is minimized. In other words, despite the fact that the valve is
engaged by longitudinal force of the luer taper, the valve is
actually opened by lateral compressive force of the cylinder wall
or projecting members, rather than the directly applied activating
longitudinal force. Therefore, it is not necessary to have a high
resisting longitudinal rebound force to achieve and maintain a
tight seal. For this reason, it is not necessary for this valve to
utilize a deadspace filler of the type described in my U.S. Pat.
No. 5,178,607, as will be discussed later. However, the
implementation of deadspace displacement or filler provides an
opportunity for utilization in valve, septum piston, or piston
configurations wherein deadspace is present and wherein it is
desirous to eliminate this deadspace so that recapping is not
necessary.
Another similar septum piston embodiment, as shown in FIG. 6A, the
septum piston 60' can include an integral latex or silicone elastic
membranous umbrella 64' which can drape over the outer walls 43 and
can be bonded or otherwise securely attached to the outer walls 43
along the umbrella end 65' when the septum piston 60' is inserted
into the proximal bore portion 34. This prevents any potential
opening at proximal end 30 adjacent inner walls 42 and septum
piston 60'. A redundant or bulging umbrella portion 66' may be
provided and the umbrella attached distally to allow the redundant
portion 66' to be free and to allow less inhibition of longitudinal
displacement of the integral septum piston 60' into the distal bore
portion 38 during operation.
In one septum piston embodiment (FIGS. 6A and 6C), a projecting
main bore occluding member 102' is provided adjacent the distal end
of the septum piston 60'. The occluding member 102' includes a
circular distal end 104' and is sized to be sealingly received into
the main bore 10 when the septum piston 60' is advanced. For
operation of this embodiment, the cylinder 18 is preferably
positioned at an angle relative to the main housing 10 and the
secondary bore 22 intersects the main bore 10 at an angle which may
be 30.degree.-90.degree. (as in FIG. 1 ). The main bore 10 is
connected distally to a distal conduit which is in fluid connection
with a patient's blood vessel. The main bore 10 is connected
proximally to a proximal conduit which is in fluid connection with
a primary fluid source, such as a high pressure flush bag or a bag
of intravenous fluid. The operation of this embodiment is similar
to the aforementioned embodiment; however, the occluding member
102' extends distally upon advancement of the septum piston 60' so
that the occluding member 102' passes the flow deflector 110' and
occludes the main bore 10 adjacent the cylinder 18 in a position
intermediate the cylinder 18 and the primary fluid source. This
embodiment provides closure of fluid connection between the
secondary bore 22 and the primary fluid source, as well as between
the patient and the primary fluid source during either aspiration
or injection of fluid from the secondary bore 22. This embodiment,
therefore, functions to open communication between the opening 94
of the luer 35 and the patient through the septum piston 60' and
the main bore 10, while at the same time automatically occluding
fluid communication between the primary fluid source and the
patient, as well as occluding communication between the primary
fluid source and the opening 94 of the luer cannula 35. During
injection, this automatically prevents reflux of fluid upstream
toward the primary fluid source and assures that the injected fluid
is injected toward the patient. During aspiration, this assures
that fluid will come from the patient and not from the primary
fluid source. The flow deflector 110 can also be sized so that it
is engaged by the distal end 61' of the septum piston 60' to
prevent excessive advancement of septum piston 60', thereby also
functioning as a septum piston stop.
In another embodiment (FIG. 6C), the septum piston 60" is shorter
and a soft deadspace filler 140" is provided. The deadspace filler
can be of the type and design for use with very blunt cannulae as
discussed in my U.S. Pat. No. 5,178,607 (the disclosure of which is
hereby incorporated by reference as if completely disclosed
herein). The soft outer filler 140" serves to minimize kickback of
the luer taper cannula 35 and functions as a deadspace occluder or
displacer. The soft filler 140" can be comprised of foam rubber
which can be covered by a medical grade silicone of the type
similar to that used in foam cuffs sold by the Bavona Corporation
for tracheostomy tubes or can be otherwise constructed to have a
similar ease compressibility and relatively low volume in the
compressed state and high volume in the resting non-compressed
state. The soft portion 140" provides a central perforation 152"
for receiving the luer taper cannula 35 through the portion 140"
and subsequently into contact with the less easily compressible
septum piston 60". Although it is preferred that the two portions
be bonded together, they may be separate and the proximal portion
may be bonded to the proximal inner walls 42 or the cylinder end 30
or may include an umbrella of the type shown in FIG. 6A or may
include another attaching member. As can be seen, the outer soft,
easily displaceable filler 140" functions as a deadspace displacer
to allow receipt of an extremely blunt cannula, such as a luer
taper cannula 35, into a fixed position in relationship with a more
stiff and less compressible valve or septum piston 60", the septum
piston 60" functions as the actual valve to provide a tight seal
and to prevent leakage of even high pressure fluid within the main
bore 10. It is the combination of a soft, easily compressible and
displaceable outer member 140" in association with a tight sealing
lower septum piston or valve 60" which achieves the ability to
splint a luer taper cannula 35 in position for reliable engagement
with the actual valve mechanism 60", while at the same time
allowing for the elimination of deadspace by the soft, easily
compressible outer member 140".
Alternative septum and housing configurations are shown in FIGS. 7
through 9. FIG. 7 is an exploded view of one preferred embodiment
showing an elastomeric septum piston 160 having cavities 161 to
increase flexibility of piston 160 and having an upper face 162,
slit 172, and including integral elastomeric tubular extension 164
defining a flexible tubular conduit 165 having an open distal end
166 and defining an interior flow path or lumen 167. The flexible
conduit is received into a cylindrical housing 168. Opposing
projecting members 169 are provided along cylindrical housing 168
to bias the septum 160 and to achieve distortion and opening of
slit 172, as described for the previous embodiments. The projecting
member 169 can be triangular in cross-section or frustrum-shaped
with a narrow apex focused directly toward the long transverse axis
of slit 172 so that maximum shortening can occur with minimum
frictional and compressive resistance to advancement of the septum.
Seats 173 are provided to receive the distal end 166 of conduit
165. Rigid tube 174 is provided for fluid communication between
flow path 167 of flexible conduit 165 and the primary tubing system
(not shown) such as a catheter connected to a patient' s vein. A
female threadable member 176 is provided for attachment to the
primary system, as discussed previously. FIG. 7A illustrates
operation of the embodiment of FIG. 7. The flexible conduit
extension 165 is compressed as the septum piston 160 is advanced
along the housing 168 by luer tip 177. Transverse compression or
distortion of septum piston 160 by projecting members 169 induces
opening of slit 172. The compression or folding of resilient
conduit 165 provides for additional rebound of septum 160 toward
its original resting position once the luer tip 177 is removed. The
flexible conduit 165 in tight sealed connection adjacent rigid tube
174 provides a closed flow path 167 to prevent contamination of
fluid passing through open slit 172.
FIG. 7B illustrates an embodiment similar to FIG. 7 with a more
thin septum piston 160' which can be more easily opened by lateral
compression. The septum piston 160' has an inwardly tapering outer
face 162'. This outer face deflects inwardly in the direction of
the longitudinal force of the advancing luer tip 177, thereby
facilitating opening of the slit 172', as shown in FIG. 7C.
FIG. 8 shows one preferred embodiment with a rigid tubular seat 180
which comprises an extension of tube 174", thereby providing a
continuous flow path 167" between the flexible conduit 165" and the
rigid tube 180. The septum piston 160" includes transverse
membranous apron extension 181 which is deflected inwardly on
displacement of the septum piston 160" into cylinder housing 168"
by the luer end 177. Apron 181 thereby facilitates circumferential
sealing of the luer tip 177 when the luer tip 177 is advanced
against septum piston face 162".
FIGS. 9 and 9A disclose an embodiment having a longer septum piston
182. This reduces the potential for deadspace and therefore
minimizes the potential for negative pressure to develop within
flow channel 183 during rebound of the piston 182 from its open
position of FIG. 9A to its closed position of FIG. 9. FIG. 9B shows
housing support 184 carried by primary tubing system 185. Septum
piston 186 is provided integral with flexible conduit 187 and
comprises the occluding proximal end of the flexible conduit. The
flexible conduit 187 is intussuscepted over and seated with tubular
wedge-shaped seat 188. A fluid deflector or ramp 189 is provided,
which can deflect fluid travelling through primary tubing system
185 into tubular seat 188 to flush out trapped air or blood
adjacent septum 186. The operation and rationale for fluid
deflection in association with blood aspiration systems is
discussed in my U.S. Pat. No. 5,137,524.
FIG. 9 shows the longer septum piston 182 having a greater diameter
in proximal area P than in distal area D. FIG. 9A illustrates
lateral compression against area P to distort the septum piston 182
into the open configuration. The embodiment of FIG. 9B uses
combined forces of lateral compression, as previously described,
and the wedge force induced by progressive compressive and/or
displacing intussusception over wedge-shaped rigid tube 188. (This
is in contradistinction to the embodiment of FIG. 7C where the
wedge effect of the luer taper is combined with lateral compression
or distortion to open the slit and allow the luer to penetrate the
slit.) With such downward displacement, the wedge force is applied
against inner walls 187a transverse to the longitudinal axis of
septum 186. This force is synergistic with the force induced by the
distorting protruding member (not visible in this figure, but shown
with previous embodiments, as 50 and 169) of housing 184 to
effectively split open the slit 172".
FIG. 12 illustrates an embodiment which combines some of the
features of FIG. 7C with those of FIG. 8 and includes additional
features, as will be discussed. The embodiment, as illustrated,
includes a septum 360 which is generally rectangular in
cross-section and which can function as a piston and/or can receive
a luer tip 177 into the septum 360, as will be discussed. The
septum 360 includes a slit 372, an apron or umbrella 381, and a
proximally projecting flexible conduit 364 defining a lumen 367.
Support housing 368 is provided, which includes projecting
supporting bars 369 having an outer flange 370 for receiving a
female threaded member of the type shown in FIG. 11. Septum 360
includes an outer deflecting member 390. Longitudinal displacement
of the septum 360 against the bars 369 causes lateral compression
force (as illustrated by arrows in FIG. 12C) against the deflecting
members 390, thereby facilitating opening of the proximal end 373
(as illustrated in FIGS. 12D through 12E). Although rounded
deflecting members 390 are shown, they may be frustrum-shaped or
triangular in cross-section to more focus the compressive force
toward slit 372.
As shown in FIG. 12 and FIG. 12C, septum 360 may include strap
members 398 extending through slots 350 to position septum 360
relative to the inlet and secure it with respect thereto.
In the preferred embodiment, the slit 372 in the resting state has
a length which is approximately equal or slightly greater than the
diameter of a conventional lure taper 177. As shown in FIG. 12D,
the transverse section of the septum defines a nearly rectangular
or elongated ellipsoid structure with the slit 372 extending
centrally along the major axis (M). The slit 372 is nearly equal in
length to the length of the major axis and is approximately equal
or slightly greater in length the diameter of the tip of the luer
taper 177. The slit divides the septum into thick walls 406 and
thin walls 400. FIG. 12E illustrates the effect of the insertion of
a luer taper 177 into the slit 372 (note that a new ellipsoid
structure is derived, having a major axis M' perpendicular to the
major axis M of the original ellipsoid septum of FIG. 12D). This
outward deflection of lateral walls 406 is accommodated by slots
350 between opposing supports 369 (see FIG. 12A); therefore,
substantial increase in the cross-sectional area of the septum 360
when filled with luer tip 177 is accommodated by deflection of a
major portion of the mass of septum 360 into slots 350, thereby
allowing fixed and narrow separation of supports 396 and flanges
370 so that opposing flanges 370 may maintain a suitable spatial
relationship for receipt of the female threaded member of a
conventional luer lock connector. The septum 360 includes annular
elevation 392 to provide a target for male luer tip 177. An angled
recess 394 is provided to facilitate wedge opening of the slit 372
by the luer taper 177. It can be seen that the wedge effect of the
luer tip 177 engaging the recess 394 is combined with the
compressive deflection force of the projecting members 369 to
provide synergistic forces to open slit 372. The diameter of the
tip of a conventional male luer end 177 is approximately 3.5-4 mm.
The internal diameter of the female threaded luer lock connector
(as shown in FIG. 11) is approximately 7-8 mm. The width of each of
the lateral walls 406 can be, for example, 1-2 mm. The distance
between the opposing flanges 370 can be, for example, 7-8 mm so
that the conventional female threaded member can be received over
and locked with the flanges 370.
It should be clear that alternative configurations of the septum
piston are possible within the scope of the present invention.
These configurations result in enhanced opening of the slit and
minimize the volume of the septum so that adequate clearance is
provided to allow insertion into septum the within the spatial
limitations defined by a conventional female threading member of a
luer lock connector. The septum piston could be otherwise
distorted, either longitudinally or horizontally, in association
with longitudinal displacement to achieve an open fluid path. It
is, however, preferable that this open fluid path extend through
the septum piston and directly in contact with the bore of the luer
taper cannula so as to facilitate flow and to absolutely minimize
the trapping of fluid or blood within the valve.
FIG. 10 shows a luer taper protecting station 190, which is
intended to protect the blunt tapered luer cannula 192 connected to
a secondary IV piggyback tubing system 194. The station 190
includes a housing 200 having an open distal end 210 and a closed
end 220 defining a chamber 222 having a bore 223. The closed end
220 preferably includes a handle rod 224 and connecting or shield
portion 226 for connection to an IV piggyback tubing or the
protection station 190 may be otherwise connected along the
piggyback system or the pole holding the piggyback system so as to
allow easy storage, as discussed in my aforementioned patent. In
the preferred embodiment, the open end 210 is occluded by an
elastomeric boot 230 which has a closed longitudinal slit 235. The
boot is preferably of thin membranous elastomeric material, such as
latex rubber or silicone and may be bonded to the housing 200 or
otherwise secured. An opening 236 in boot 230 is preferably
provided to receive the thread receiving post 244 which is tall
enough to threadably engage with the female threading member which
is carried by a conventional luer lock connector without disruption
of the boot 230. If necessary to prevent the threads of the luer
lock from potentially disrupting the boot during threading, two
tall posts may be provided on opposite sides of the housing 200.
The boot 230, when attached to the distal end of the station 190,
produces a distal face 250 which is easily swabbable with
antiseptic. As noted, the boot 230 material is preferably
membranous elastic and resilient so that, despite the fact that the
male luer taper 192 is close in diameter to the internal transverse
dimension of the bore of the station, the elastic boot can be
deflected laterally against the inner walls 254 of the station 190
so that even the large diameter of a luer taper 192 can be received
within the bore 223 of the station 190 without being inhibited by
the low displacement volume and, indeed, easily displaceable
elastic boot 230. This is an important feature since there is
relatively little clearance between the outer surface 256 of a
conventional male tapered luer cannula 192 and the inner surface
260 of the threadable luer lock connector 270 surrounding the taper
192 which must be received over the station 190. It is, therefore,
important that the sealing member has a very low displacement or
compressed volume so that luer lock connector 270 may be fully
received over and through the boot 230 and into the station 190
without the advancement of the cannula 192 fully into the bore 222
being inhibited by the displaced face 250 of boot 230.
Although an elastic membranous boot is shown, a perforated
deadspace filler, of the type previously discussed with a
compressed low displacement volume, may be used to fill the bore of
the station and to receive and cover the luer taper.
Although the presently preferred embodiments of this invention have
been described, it will be obvious to those skilled in the an that
various changes and modifications may be made therein without
departing from the invention. Therefore, the claims are intended to
include all such changes and modifications which may be made
therein without departing from the invention. Therefore, the claims
are intended to include all such changes and modifications that
fall within the true spirit and scope of the invention.
* * * * *